Prosthetic devices

ABSTRACT

Expandable prosthetic devices used for treating a variety of conditions, including rotator cuff injuries, broken and/or depressed bone fractures, infection and/or inflammation in the body. In one embodiment, a prosthesis includes an implant having a pressure regulating valve. The implant is capable of being positioned between a first tissue and an opposing second tissue in a void space and of deforming under pressure in response to articulation of a joint. The pressure regulating valve is configured to open based on a predetermined pressure in the implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/076,109, filed on Mar. 21, 2016, which is a divisional of U.S.application Ser. No. 14/352,614, filed on Apr. 17, 2014 (now U.S. Pat.No. 9,289,307), which is a national phase filing under 35 U.S.C. 371 ofInternational Application No. PCT/IB2012/002088, filed on Oct. 18, 2012,which claims the benefit of U.S. Provisional Application No. 61/548,232.The entirety of the disclosures of the prior applications are hereinincorporated by reference.

FIELD OF INVENTION

The present inventions relate generally to the field of medical devicesand the treatment of human medical conditions using the medical devices.More specifically, the present inventions include expandable prostheticdevices used for treating a variety of conditions, including rotatorcuff injuries, broken and/or depressed bone fractures, infection and/orinflammation in the body.

BACKGROUND

Through repeated strenuous motion, sensitive soft tissues often sufferwear and tear injuries from repeatedly rubbing against one anotherand/or hard tissues, such as bone. Tears of rotator cuff tendons andarticular capsule disintegration are examples of this type of injury. Inaddition, these tissues can be adversely affected by inflammation,infection, disease and/or genetic predispositions which lead todegeneration of these tissues.

Severe or complete tears and deterioration of articulations (i.e.,bodily joints) related tissues (such as tendons, ligaments, capsules,cartilage and bony parts), and other bodily elements (such as bursae,synovium and other membranes) may cause severe pain, hindered movementup to complete disability, joint parts dislocation, and other possiblephenomena.

Some joints related deteriorations can be amended by filling voids andspaces between tissues with volumetric fillers especially in scenarioswhere there is a need to create or revive unhindered relative motionbetween such tissues. Such volumetric fillers should possess specificcombined characteristics such as 3D geometry, external surface textureand overall consistency in order to avoid inefficacy on the one hand andstiff sensation on the other. Since that patients differ much on suchvoids geometries, mechanical and physical properties of voids'boundaries, and overall shoulder consistency, weight and strength, it istherefore needed that the volumetric fillers will be patient-specific inthe sense that it will be deployed, shaped and fine-tuned in vivo.

SUMMARY

In some embodiments, the present invention includes a method ofimplanting a prosthesis in a body that includes at least the followingsteps: providing a prosthesis that includes at least an implant capableof deformation under pressure; inserting the implant in a void space ina joint; inflating the implant by adding a first amount of filler to theimplant where the first amount of filler is X; articulating the joint;releasing a second amount of filler from the implant where the secondamount of filler released from the implant is Y; and sealing the implantwhere X is greater than Y. In some embodiments, inflating the implant byadding a first amount of filler causes the implant to fully expand,fully unroll, and/or expand a void to a predetermined shape and/or size.

In some embodiments, the articulating the joint step and the releasing asecond amount of filler from the implant where the second amount offiller released from the implant is Y step occur concomitantly. In someembodiments, the releasing a second amount of filler from the implantwhere the second amount of filler released from the implant is Y step iscaused by the articulating the joint step.

In some embodiments, the method includes the implant having a first faceand an opposing second face, where the method further includesarticulating the joint to result in a predetermined distance between thefirst face of the implant and the opposing second face of the implant,where the predetermined distance between the first face of the implantand the opposing second face of the implant is greater than 0millimeters.

In some embodiments, the ratio of X:Y is less than or equal to 4:1. Insome embodiments, the ratio of X:Y is less than or equal to 2:1. In someembodiments, the ratio of X:Y is less than or equal to 1.3:1.

In some embodiments, the implant is a bladder. In some embodiments, theimplant is formed of a biodegradable material. In some embodiments, theimplant is formed of a biodegradable material that may includepolycaprolactone, polyglycolide, polyhydroxybutyrate, plastarchmaterial, polyetheretherketone, zein, polylactic acid, polydioxanone,poly(lactic-co-glycotic acid), poly(lactice acid-co-epsiloncaprolactone), collagen, and/or methyl cellulose.

In some embodiments, the joint is a mammalian joint. In someembodiments, the joint is a shoulder joint.

In some embodiments, the filler includes at least a biocompatible fluid.In some embodiments, the filler includes at least a biocompatible fluidthat is saline.

In some embodiments, the method includes a step of inflating the implantsufficiently to contact at least one surface of a tissue in the joint.

In some embodiments the method includes articulating the joint thatincludes at least a forward flexion, an abduction, an external rotation,an internal rotation and/or a cross-body adduction.

In some embodiments, the present invention includes a method ofimplanting a prosthesis in a body that includes at least the followingsteps: providing a prosthesis that includes at least an implant capableof deformation under pressure; inserting the implant in a void space ina joint; inflating the implant by adding a first amount of a filler tothe implant, where the first amount of the filler is X; articulating thejoint; releasing a second amount of the filler from the implant througha pressure regulating valve based on a predetermined pressure in theimplant, where the second amount of the filler released from the implantis Y; and sealing the implant, where X is greater than Y. In someembodiments, the joint is a shoulder joint.

In some embodiments, the implant includes the pressure regulating valve.In some embodiments, the pressure regulating valve is external from theimplant.

In some embodiments, the predetermined pressure in the implant is atleast 8 pounds per square inch. In some embodiments, the predeterminedpressure in the implant is at least 12 pounds per square inch. In someembodiments, the predetermined pressure in the implant is at least 20pounds per square inch.

In some embodiments, the method further includes releasing filler fromthe implant into the void space in the joint.

In some embodiments, the articulating the joint step and the releasing asecond amount of filler from the implant through a pressure regulatingvalve based on a predetermined pressure in the implant, where the secondamount of filler released from the implant is Y step occurconcomitantly. In some embodiments, the releasing a second amount offiller from the implant through a pressure regulating valve based on apredetermined pressure in the implant, where the second amount of fillerreleased from the implant is Y step is caused by the articulating thejoint step.

In some embodiments, the ratio of X:Y is less than or equal to 2:1.

In some embodiments, the present invention is a prosthesis having animplant having a pressure regulating valve, where the implant is capableof being positioned between a first tissue and an opposing second tissuein a joint, where the implant is capable of deforming under pressure inresponse to articulation of the joint, and where the pressure regulatingvalve is configured to open based on a predetermined pressure in theimplant.

In some embodiments, the implant is a fluid filled bladder. In someembodiments, the pressure regulating valve is configured to open basedon a predetermined pressure of 8 pounds per square inch. In someembodiments, the fluid filled bladder is filled with saline. In someembodiments, the implant and/or the pressure regulating valve are formedof a biodegradable material.

In some embodiments, the filler includes, at least a biocompatiblefluid. In some embodiments, the filler includes at least a biocompatiblefluid that is saline. In some embodiments, the pressure regulating valveis formed of a biodegradable material.

In an aspect of some embodiments, there is provided a prosthesis use ina mammalian joint. In some embodiments, the prosthesis includes animplant configured for spacing the tissue associated with articulationaway from adjacent tissue. In some embodiments, the implant is capableof being deforming to accommodate for pressure applied thereupon by thetissue associated with articulation and/or the adjacent tissue. In someembodiments, the implant is subject to viscoelastic deforming orresembling viscoelastic-like behavior. Optionally, the implant is formedfrom a biodegradable material.

In some embodiments, the pressure applied to the implant results frommovement of tissue associated with articulation and/or the adjacenttissue. Optionally, the implant is sized and configured for a rotatorcuff tissue.

In some embodiments, the implant is a fluid filled bladder, optionallypartially filled, optionally filled with saline. In some embodiments,the deforming does not result in a substantial increase in stress on awall of the bladder. In some embodiments, the bladder is formed from anon-compliant or a semi-compliant material. In some embodiments, aninternal fluid pressure of the fluid filled bladder does not rise above8 psi during the deforming.

In some embodiments, the fluid filled bladder includes a valve forregulating a fluid pressure within the bladder. The value may beconfigured for releasing fluid out of the fluid filled bladder above apredetermined internal fluid pressure, optionally 8 psi. Optionally, thevalve is biodegradable. In some embodiments, a system is providedcomprising the implant and an inflation apparatus detachably coupled tothe bladder.

In an aspect of some embodiments, there is provided a prosthesis for usein the articulation of a mammalian joint comprising an implantconfigured for providing floatation-like support to the tissueassociated with articulation thereby minimizing interface pressure andfriction on tissue associated with articulation.

Also provided, in accordance with some embodiments of the invention, isa method of implanting a prosthesis configured for use in thearticulation of a mammalian joint. In some embodiments, the methodincludes implanting the prosthesis in contact with the tissue associatedwith articulation, and articulating the joint, thereby enabling theprosthesis to deform and accommodate for pressure applied thereupon bythe tissue associated with articulation and/or adjacent tissue.

In some embodiments, the tissue associated with articulation is arotator cuff tendon, a humerus, an acromion or a coracoid process.

In some embodiments, the method further includes measuring a naturalvoid between a limb bone and an adjacent trunk bone surrounding thejoint and selecting the prosthesis according to a size and/or shape ofthe void. Optionally, the limb bone is a humerus and the trunk bone isan acromion or a glenoid.

In some embodiments, the prosthesis is a fluid expandable bladder andthe method includes expanding the prosthesis to a first size and/or ashape prior to articulation the joint. Optionally, joint articulationresults in deformation of the prosthesis to a second size and/or ashape. The second size and/or the shape may result from release of fluidfrom the bladder. Optionally, the bladder is sealed at the second sizeand/or the shape.

In some embodiments, articulating the joint is through a full range ofmotion, optionally a passive range of motion, optionally any of aforward flexion, an abduction, an external rotation, an internalrotation and a cross-body adduction.

In some embodiments, the method further includes debriding tissues inthe natural void, Optionally, the method further includes fixating theprosthesis in position. In some embodiments, the bladder includes atleast one smooth surface and the second size and/or the shape impose apredetermined friction characteristic between the at least one smoothsurface and the tissue associated with articulation. Optionally, thefriction characteristic is at least one of a static dry friction force,a kinetic friction force, a friction coefficient and a normal forceapplied to the tissue type in continuous contact with the smoothsurface. Optionally, the friction characteristic allows a chosentransient between a static friction force and a kinetic friction force,thereby allowing movement of the prosthesis in a stable equilibriumpositioning.

In an aspect of some embodiments, the prosthesis includes a tissuepositioning device, comprising: a biocompatible member having a size andshape suitable for placement within a space adjacent to a tissue to bepositioned, the tissue forming a portion of an articulatable joint; suchthat, when placed within the space, the member acts to maintain thetissue in a desired position. Optionally, the member is a spacer whichhas a defined shape when acting to maintain the tissue in the desiredposition. Optionally, the member arranged such that its size and shapeare suitable for placement within a given space and for positioning aparticular tissue. In some embodiments, the member comprises: a bladderhaving an associated deflated state and which is capable of receivingand being at least partially expanded by a filler material; and a valveby which a filler material can be delivered into the bladder; such thatthe bladder is capable of insertion into the space when in the deflatedstate and acts to maintain the tissue in the desired position when atleast partially expanded by the delivery of filler material via thevalve. Optionally, the tissue is hard or soft tissue. Optionally, thespace is between the acromium, deltoid muscle, and humerus, such that,while placed within the space, the member acts to maintain the head ofthe humerus within the cup of the glenoid.

An aspect of some embodiments of the invention relates to prosthesesadapted to reduce injuries between soft tissues of the body and othertissues. In an embodiment of the invention, soft tissues are forexample, tendons and/or ligaments. In an embodiment of the invention,other tissues are, for example, bones. In an embodiment of theinvention, the prosthesis is expandable. Optionally, the prosthesis iselastic. In some embodiments of the invention, the prosthesis is rigid.In an embodiment of the invention, the prosthesis is shaped and/or sizedto simulate a bursa naturally occurring in the body. Optionally, thebursa simulated is the one expected to be present at the implantationsite of the prosthesis in a healthy patient.

Optionally, the expandable prosthesis is sponge-like. Optionally, theexpandable prosthesis is inflatable. In some exemplary embodiments ofthe invention, the expandable prosthesis is adapted to be insertedbetween the tendons of the rotator cuff and the acromion and/or coracoidprocess. Expandable prosthesis is biocompatible and/or biodegradable, inan exemplary embodiment of the invention. Optionally, the expandableprosthesis is adapted to elute pharmaceutical agents once implanted in apatient's body. In an embodiment of the invention, inflatable expandableprosthesis is inflated with filler, for example a gas, liquid, and/orgel. Optionally, the filler is biocompatible and/or biodegradable,and/or contains the pharmaceutical agents. In some embodiments, elutionof pharmaceutical agents is according to a schedule timed with thebiodegradable properties of the expandable prosthesis. In someembodiments of the invention, the prosthesis is only partially filled.

In some embodiments of the invention, the prosthesis is provided withanchoring devices adapted to maintain the prosthesis in a steadyrelationship with the anatomical features around the implantation site.Optionally, the prosthesis is contoured along its exterior toaccommodate anatomical features around the implantation site.

An aspect of some embodiments of the invention relates to a method forimplanting an expandable prosthesis adapted to reduce and/or eliminateinjury between soft tissues of the body and other tissues, for exampleto the rotator cuff. In an embodiment of the invention, the expandableprosthesis is either sponge-like or inflatable and is expanded in aspace between the tendons of the rotator cuff and the acromion and/orcoracoid process. In some embodiments of the invention, a prosthesisimplantation and/or inflation device is used to implant and/or inflatethe expandable prosthesis.

An aspect of some embodiments of the invention relates to an expandableprosthesis for treating inflammation and/or infection. Optionally, theexpandable prosthesis is a sponge-like structure, sponge-like beingdefined as including at least one of the following properties: porous,absorbent and/or compressible. Optionally, the expandable prosthesis isinflatable. Expandable prosthesis is biocompatible and/or biodegradable,in an exemplary embodiment of the invention. Optionally, the expandableprosthesis is adapted to elute pharmaceutical agents once implanted in apatient's body. Expandable sponge-like device optionally contains withinits cavities at least one biocompatible and/or biodegradable gellingmaterial that expands when it comes into contact with at least onebodily fluid, for example by absorbing water.

In an embodiment of the invention, inflatable expandable prosthesis isinflated with filler, for example a gas, liquid, and/or gel. Optionally,the filler is biocompatible and/or biodegradable and/or contains thepharmaceutical agents. In some embodiments, elution of pharmaceuticalagents is according to a schedule timed with the biodegradableproperties of the expandable prosthesis.

In an embodiment of the invention, at least one section of theprosthesis is inflated with filler, for example a gas, liquid, cementand/or gel. Optionally, the filler is biocompatible and/orbiodegradable. In some embodiments of the invention, the expandableprosthesis is adapted to have at least one section removed prior toclosing the patient. In an embodiment of the invention, at least onesection is adapted to withstand the expected pressures. In an embodimentof the invention, the expandable prosthesis is inflated and/or implantedusing a plurality of prosthesis inflation and/or implantation devices.

An aspect of some embodiments of the invention relates to a prosthesisimplantation and/or inflation device. In an embodiment of the invention,the prosthesis implantation and/or inflation device includes a syringedesigned to inject filler into an expandable prosthesis, for examplethrough a tube which operatively connects syringe to the expandableprosthesis. In some embodiments of the invention, the syringe iscomprised of at least a plunger and a canister. Optionally, the plungeris advanced through the canister by the device in order to inject fillerinto the prosthesis. Optionally, the canister is advanced against theplunger, which remains relatively fixed due to counterforce from abackstop, in order to inject filler into the prosthesis.

In some exemplary embodiments of the invention, the prosthesisimplantation and/or inflation device includes a safety. Optionally, thesafety comprises at least a spring and a ball, wherein the ball acts asa counterpart to a groove in the backstop. Excessive force on thebackstop by continued advancement of the canister towards the plungertriggers the safety, popping the ball out of the groove and freeing thebackstop to move. In an embodiment of the invention, the placement ofthe backstop is according to a predetermined level of desired inflationof the prosthesis.

There is thus provided in accordance with an embodiment of theinvention, a prosthesis comprising: a member designed to simulate atleast one of a size or a shape of a naturally occurring bursa.

In an embodiment of the invention, the member is expandable. Optionally,the member is designed to be at least partially inflated. Optionally,the member is inflated sufficiently to reduce rubbing of the softtissues against other tissues while permitting at least some movement ofthe soft tissues relative to the other tissues. Optionally, at leastsome movement of the soft tissues relative to the other tissues is fullmovement. In an embodiment of the invention, the member is sponge-like.Optionally, the sponge-like member is provided with a fluid absorbentmaterial which when fluids are absorbed induces expansion of thesponge-like expandable member.

In an embodiment of the invention, the prosthesis is constructed of atleast one of a biocompatible or biodegradable material. Optionally, theat least one of a biocompatible or biodegradable material ispoly(lactice acid-co-epsilon caprolactone), PCL, PGA, PHB, plastarchmaterial, PEEK, zein, PLA, PDO, PLGA, collagen or methyl cellulose.

In an embodiment of the invention, the prosthesis is constructed of atleast one non-biodegradable material. Optionally, the at least onenon-biodegradable material is polyethylene, polyurethane, silicon, orpoly-paraphenylene terephthalamide.

In an embodiment of the invention, the prosthesis further comprises arigid ring having a lumen therein attached to the member, wherein thelumen provides fluid communication to an inner space of the member.

In an embodiment of the invention, the prosthesis further comprises aplug designed to lodge in the lumen thereby sealing the inner space ofthe member. Optionally, the plug is constructed of at least one of abiocompatible or biodegradable material.

In an embodiment of the invention, the member is elastic.

In an embodiment of the invention, the prosthesis further comprises atleast one anchoring device for stabilizing the prosthesis uponimplantation. Optionally, the at least one anchoring device isconstructed of at least one of a biocompatible or biodegradablematerial.

In an embodiment of the invention, the member is contoured to act as acounterpart to natural anatomical features of an implantation site.

In an embodiment of the invention, the member is designed to elute atleast one pharmaceutical agent.

In an embodiment of the invention, the size of the prosthesis isapproximately 2 cm to 15 cm in length, optionally 10 cm or less, along along axis, approximately 2 cm to 10 cm in length, optionally 7 cm orless, along a short axis and approximately 0.5 mm to 20 mm in height,when expanded.

In an embodiment of the invention, the member is rigid. Optionally, themember is contoured to act as a counterpart to natural anatomicalfeatures of an implantation site while permitting at least some movementof the soft tissues relative to other tissues.

In an embodiment of the invention, the member is designed for use in arotator cuff. In an embodiment of the invention, the member is designedfor use in at least one of a flexor or an extensor. In an embodiment ofthe invention, the member is designed for use between a quadriceps and afemur. In an embodiment of the invention, the member is designed for usebetween a skin and a plantar fascia and a calcaneus of the body. In anembodiment of the invention, injury is at least one of inflammation orinfection.

There is further provided in accordance with an exemplary embodiment ofthe invention, a method for implanting a prosthesis between soft tissuesand other tissues of a body, comprising: placing the prosthesis into animplantation site between the soft tissues and the other tissues; and,simulating with the prosthesis a bursa naturally occurring at theimplantation site. In an embodiment of the invention, the method furthercomprises eluting at least one pharmaceutical agent from the prosthesisat the implantation site. Optionally, placing and simulating occurswithout significantly reducing movement of the soft tissues relative tothe other tissues. Optionally, the soft tissues are tendons of a rotatorcuff and the other tissues are at least one of a humerus, an acromion ora coracoid process.

There is further provided in accordance with an exemplary embodiment ofthe invention, a system for sealing an inflatable prosthesis,comprising: a prosthesis inflation device; a tube operatively connectedto the prosthesis near one end and the prosthesis inflation device onthe other end; a plug attached to the tube at the prosthesis end of thetube; and, a rigid ring attached to the prosthesis and slidably attachedaround the tube between the prosthesis inflation device and the plug;wherein pulling the tube towards the prosthesis inflation device causesplug to lodge in the rigid ring, sealing the prosthesis with the plug.Optionally, the plug is attached to the tube by gripping protrusions.

There is further provided in accordance with an exemplary embodiment ofthe invention, a method of sealing an inflatable prosthesis, comprising:pulling a tube out of the prosthesis and through a rigid ring; and,lodging a plug located on the end of the tube in the rigid ring.

DESCRIPTION OF DRAWINGS

Non-limiting embodiments of the invention will be described withreference to the following description of exemplary embodiments, inconjunction with the figures. The figures are generally not shown toscale and any measurements are only meant to be exemplary and notnecessarily limiting. In the figures, identical structures, elements orparts which appear in more than one figure are preferably labeled with asame or similar number in all the figures in which they appear, inwhich:

FIG. 1 is an illustration of a sponge-like expandable prosthesis inaccordance with an exemplary embodiment of the invention;

FIG. 2 is a cutaway view of a portion of a prosthesis implantationand/or inflation device and an inflatable expandable prosthesis, inaccordance with an exemplary embodiment of the invention;

FIG. 3 is an anatomical view of a human shoulder with an expandableprosthesis in vivo, in accordance with an exemplary embodiment of theinvention;

FIGS. 4A-C are cutaway side views showing the progression removablyattaching a prosthesis implantation and/or inflation device and anexpandable prosthesis, in accordance with an exemplary embodiment of theinvention;

FIG. 5 is a cutaway side view of a portion of a prosthesis implantationand/or inflation device including a counter-pressure sheath and anexpandable prosthesis, in accordance with an exemplary embodiment of theinvention;

FIG. 6 is a cutaway side view of an alternative sealing mechanism, inaccordance with an exemplary embodiment of the invention;

FIGS. 7A-B are flowcharts demonstrating methods of implanting anexpandable prosthesis, in accordance with some exemplary embodiments ofthe invention;

FIG. 7C is a diagram demonstrating pressure-change graphs of a pressureregulated expandable prosthesis versus an over-inflated and anunder-inflated expandable prostheses, in accordance with some exemplaryembodiments of the invention;

FIG. 8 is a cutaway side view of an expandable prosthesis packed priorto use, in accordance with an exemplary embodiment of the invention;

FIG. 9 is a perspective view of a device in accordance with an exemplaryembodiment of the invention;

FIG. 10 is an isometric view of a prosthesis implantation and/orinflation device and an inflatable expandable prosthesis, in accordancewith an exemplary embodiment of the invention;

FIG. 11 is a cutaway view of an expandable prosthesis deployed in aglenohumeral joint, in accordance with an exemplary embodiment of theinvention;

FIGS. 12A-C are schematic cut views of a prosthesis and a portion of animplantation and/or inflation device comprising a pressure regulatingvalve, in accordance with an exemplary embodiment of the invention; and

FIGS. 13A-E are schematic cutaway views and an isometric viewillustrating deployment stages of a prosthesis between two adjacentjoint related tissues, in accordance with an exemplary embodiment of theinvention.

DETAILED DESCRIPTION

Among those benefits and improvements that have been disclosed, otherobjects and advantages of this invention will become apparent from thefollowing description taken in conjunction with the accompanyingfigures. Detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely illustrative of the invention that may be embodied in variousforms. In addition, each of the examples given in connection with thevarious embodiments of the invention which are intended to beillustrative, and not restrictive.

Throughout the specification and claims, the following terms take themeanings explicitly associated herein, unless the context clearlydictates otherwise. The phrases “In some embodiments” and “in someembodiments” as used herein do not necessarily refer to the sameembodiment(s), though it may. Furthermore, the phrases “in anotherembodiment” and “in some other embodiments” as used herein do notnecessarily refer to a different embodiment, although it may. Thus, asdescribed below, various embodiments of the invention may be readilycombined, without departing from the scope or spirit of the invention.

In addition, as used herein, the term “or” is an inclusive “or”operator, and is equivalent to the term “and/or,” unless the contextclearly dictates otherwise. The term “based on” is not exclusive andallows for being based on additional factors not described, unless thecontext clearly dictates otherwise. In addition, throughout thespecification, the meaning of “a,” “an,” and “the” include pluralreferences. The meaning of “in” includes “in” and “on.”

As described above, repeated strenuous motion often causes sensitivesoft tissues associated with a mammalian joint to suffer wear and tearinjuries from repeatedly rubbing against one another and/or hardtissues, such as bone. Tears of tendons and/or ligaments and articularcapsule disintegration are examples of this type of injury. In addition,these tissues can be adversely affected by inflammation, infection,disease and/or genetic predispositions which lead to degeneration ofthese tissues.

Injuries to soft tissues such as tendons can cause pain and impairedfunction of the area served by the tendon. Typically, a bursa can befound near areas where “friction” injuries due to the rubbing are proneto occur. A bursa is a natural fluid collection that permits movementsbetween tendons and/or ligaments and bone parts and prevents injury tothese tendons by acting as a cushion and/or movement facilitator betweenthem.

In some embodiments of the invention, prostheses described herein areshaped and/or sized to simulate the natural bursa found in the intendedarea of implantation. For example, in some of the rotator cuffembodiments described below, the described exemplary prostheses areshaped and/or sized to simulate the subacromial bursa. Optionally, insome embodiments, the prostheses are sized to supplement a natural bursawhich is misshapen and/or undersized, bringing the combination of thenatural bursa and the prosthesis into line with the shape and/or size ofa healthy bursa.

In some embodiments of the invention, prostheses described hereinpossess characteristics. In some embodiments, the prostheses describedherein are designed and configured to gently resist an immersion of abony prominence and to slowly regain at least partially an expanded sizeonce normal stresses diminishes.

In some embodiments of the invention, prostheses described hereininclude an inflatable chamber (e.g., a bladder) having at least onemalleable wall, optionally elastic or semi-elastic, optionally made froma non-compliant or a semi-compliant material, provided in contact with abony prominence under dynamic and continuously changing pressures andimmersion capacities. In some embodiments, the wall is subjected todeform by at least partially imprinting immersions, optionally itsdeforming does not result in a substantial increase in stress therein.In some embodiments, the malleable wall is supported with a fluid,either Newtonian or non-Newtonian, which fills the chamber to a lessthan a maximal inflation volume and therefore allowed to freely flow andredistribute under continuously changing chamber form and/or volume. Insome embodiments, the chamber is filled to a certain chosen degree inorder that the chamber will avoid bottoming under maximally knowncompressive forces, in the sense that any opposing surfaces thereof willnot engage. In some embodiments, a chosen filling volume ispatient-specific, optionally determined according to a maximally allowedelevated in-chamber pressure at a maximally known compressive force. Insome embodiments, the chamber includes at least two opposing walls incontinuous contact with two opposing body prominences of a mammalianjoint/articulation. In some embodiments, the walls are nonstretchable intransverse plane of the prosthesis under normal sear forces created inthe articulation but is pliable other planes. In some embodiments, theat least one wall or at least two walls are peripherally and/orlaterally supported with a stiffer portion of the chamber, acting as aframe support.

In some embodiments of the invention, the described exemplary prosthesesare implanted in a collapsed form thereby allowing minimally invasiverelated techniques and instrumentation. In some embodiments, suchimplantation may include a delivery to site via a small incision and/orcreated passage having a maximally preferred size (e.g., diameter) equalor less than 5 mm, optionally equal or less than 3 mm.

In some embodiments, the described exemplary prostheses are expanded insite to a first form and/or size, thereby irreversibly uncollapsible.

In some embodiments, the described exemplary prostheses are expandedand/or contracted from the first form and/or size to a second formand/or size, thereby achieving a chosen dimension, characteristic and/orfunctionality derived from the prostheses form and/or size.

In some embodiments, the described exemplary prostheses are regulatedsuch to contract down to a patient-specific and/or a minimal valueand/or to build a maximally allowed inner pressure, thereby to provide achosen prosthesis consistency (e.g., a maximal malleability) but stillmaintain a minimally allowed distance and/or avoiding any physicalcontact between adjacent tissues (e.g., adjacent joint bones) under anynon-breaking compressive stresses applied to the implanted prosthesis.In some embodiments, the pressure regulated expandable prostheses of thepresent invention are singularly programmed or calibrated to a patient,in vivo, to thereby set a maximally allowed generated pressure to amaximal prosthesis contraction under a certain movement scenario of ahosting environment (e.g., the host shoulder).

In some embodiments, the present invention relates to joints including,but not limited to shoulder joints and bodily areas adjacent jointsand/or interlinked with joints' function, such as the rotator cuff. Therotator cuff is an anatomical term given to the group of muscles andtheir tendons that act to stabilize the shoulder and to permit rotationand abduction of the arm. Along with the teres major and the deltoid,the four muscles of the rotator cuff make up the six muscles of thehuman body which connect to the humerus and scapula. Injury to thetendons and/or these muscles can cause pain and impaired function of theshoulder. The subacromial bursa is a natural fluid collection thatpermits movement of these rotator cuff tendons beneath the acromion andcoracoid process, both of which are part of scapula bone. In somerotator cuff injuries, the subacromial bursa becomes inflamed andsuffers from a reduced ability to prevent injury to the tendons throughfriction.

Referring to FIG. 1, an expandable prosthesis I00 is shown as anexemplary embodiment of the invention. In an exemplary embodiment of theinvention, expandable prosthesis 100 is introduced between the abovementioned acromion and coracoid processes and the rotator cuff tendonsand designed to permit relatively unhindered (relative to the movementafforded to the shoulder without treatment) or free shoulder movement,shown and described in more detail with respect to FIG. 3. In someembodiments of the invention, expandable prosthesis 100 comprises anexpandable member which is a sponge-like structure. In some embodiments,the sponge-like expandable prosthesis 100 is adapted to elutepharmacological substances such as anti-inflammatory and/or antibioticand/or pro-angiogenesis substances, in some exemplary embodiments of theinvention.

In an exemplary embodiment of the invention, the expandable prosthesis100 is biodegradable and/or biocompatible. In some embodiments, thesponge-like structure is manufactured from at least one biodegradableand/or biocompatible synthetic material such as, but not limited to,polycaprolactone (“PCL”), polyglycolide (“PGA”), polyhydroxybutyrate(“PHB”), plastarch material, polyetheretherketone (“PEEK”), zein,polylactic acid (“PLA”), polydioxanone (“PDO”), poly(lactic-co-glycolicacid) (“PLGA”), poly(lactice acid-co-epsilon caprolactone) or anycombination and/or family members thereof. In some exemplary embodimentsof the invention, the sponge-like structure is manufactured from atleast one “naturally-derived” biodegradable and/or biocompatiblematerials such as collagen and/or methyl cellulose. In an exemplaryembodiment of the invention, sponge-like expandable prosthesis 100 isimparted expandable properties, at least in part, by placing within itscavities at least one biocompatible and/or biodegradable material whichexpands after coming into contact with fluids. Optionally, in someembodiments, the fluids are bodily fluids. Optionally, in someembodiments, the at least one biocompatible and/or biodegradablematerial is a gel.

In some embodiments, the implant can be used to prevent pain and/orfriction for a predetermined duration during which there is at leastpartial self-healing of adjacent tissues. In some embodiments, theimplant can be used until it is punctured and/or degraded.

In some exemplary embodiments of the invention, sponge-like expandableprosthesis 100 is non-biodegradable. Non-biodegradable expandableprostheses are manufactured of biocompatible materials such aspolyethylene, Kevlar® (poly-paraphenylene terephthalamide), polyurethaneor silicon, or any combination thereof, in some embodiments of theinvention. In some exemplary embodiments of the invention, theexpandable prosthesis is manufactured from biologically derived,biocompatible and/or biodegradable materials such as collagen. In anexemplary embodiment of the invention, prosthesis 100, when expanded,has approximately the same dimensions as other prostheses when expanded,described below.

Referring to FIG. 2, a cutaway view of a portion of a prosthesisimplantation and/or inflation device 200 and a prosthesis 202 with anexpandable member which is inflatable is shown, in accordance with anexemplary embodiment of the invention. In an exemplary embodiment of theinvention, inflatable expandable prosthesis 202 is introduced betweenthe acromion and coracoid processes and the rotator cuff tendonsdesigned to permit relatively unhindered or free shoulder movement,shown and described in more detail with respect to FIG. 3. Optionally,in some embodiments, alternatively and/or additionally, an expandableprosthesis comprises an inflatable structure and a sponge-like structurein combination.

In an exemplary embodiment of the invention, inflatable expandableprosthesis 202 is rectangular shaped when deflated and resembles acuboid parallelepiped when inflated. In an exemplary embodiment of theinvention, inflatable expandable prosthesis 202 is circular or oval inshape when deflated and when inflated resembles a cylindrical disc orovoid. In some embodiments, many shapes could be adapted to be implantedbetween the acromion and coracoid processes and the rotator cuff tendonsdesigned to permit relatively unhindered or free shoulder movement for apatient, in an exemplary embodiment of the invention. In someembodiments of the invention, prosthesis 202 is adapted to be inserteddeflated into a patient's body through a cannula. Optionally, in someembodiments, the cannula is a 5 mm-7 mm cannula. In an embodiment of theinvention, a long axis 207 (x-axis) of inflatable expandable prosthesis202 is approximately 2 cm to 10 cm in length when inflated, in someembodiments of the invention, a short axis 208 (y-axis) of inflatableexpandable prosthesis 202 is approximately 2 cm to 10 cm in length wheninflated. In some exemplary embodiments of the invention, inflatableexpandable prosthesis 202 is 0.5 mm to 20 mm in height (z-axis).Optionally, in some embodiments, inflatable expandable prosthesis 202 is1 mm to 10 mm in height. In some embodiments, the deflated and/orinflated size of prosthesis 202 may be adapted to fit for a patient'sparticular needs or to simulate the size and/or shape of the naturalbursa, in an embodiment of the invention, and therefore, prosthesis 202does not necessarily conform to the size ranges given above.

In some embodiments, inflatable expandable prosthesis 202 ismanufactured by dip molding, in an exemplary embodiment of theinvention. In some embodiments of the invention, inflatable expandableprosthesis 202 is a seamless balloon-like structure made frombiocompatible and/or biodegradable synthetic materials such as, but notlimited to; PCL, PGA, PHB, plastarch material, PEEK, zein, PLA, PDO,PLGA, poly(lactice acid-co-epsilon caprolactone) or any combinationand/or family members thereof.

Additionally, optionally and/or alternatively, in some embodiments,inflatable expandable prosthesis 202 is manufactured from natural,biocompatible and/or biodegradable materials such as collagen and/ormethyl cellulose. In some exemplary embodiments of the invention, theinflatable prosthesis 202 is manufactured from at least onenon-biodegradable material such polyethylene, polyurethane, silicon,and/or Kevlar®. In an embodiment of the invention, prosthesis 202 iscomprised of a material which is approximately 100-200 microns inthickness, although, as with the other dimensions, the thicknessdimension of the material is adapted depending on the intended useand/or the needs of the patient. In some exemplary embodiments of theinvention, inflatable expandable prosthesis 202 is adapted to elutepharmaceuticals such as anti-inflammatory drugs and/or antibioticsand/or pro-angiogenesis factors to promote healing.

Inflatable expandable prosthesis 202 is releasably attached toprosthesis implantation and/or inflation device 200, in an exemplaryembodiment of the invention. Prosthesis implantation and/or inflationdevice 200 is adapted to inflate and/or deflate prosthesis 202, allowprosthesis 202 to be positioned in vivo, and/or separate from prosthesis202 after implantation, leaving prosthesis 202 at the implantation site,in an embodiment of the invention. In some exemplary embodiments of theinvention, prosthesis implantation and/or inflation device 200 includesa tube or catheter type structure 204 which interfaces with prosthesis202 in the proximity of a sealing mechanism 206 which is located at theend of tube 204 nearest prosthesis 202.

In an embodiment of the invention, sealing mechanism 206 includes a plug402, shown in FIG. 4B inter alia, attached to the end of tube 204nearest prosthesis 202. In an embodiment of the invention, plug 402 isconstructed of the same material or materials as any of the prosthesesdescribed herein. In some embodiments, tube 204 is adapted to allowpassage therethrough of a filler to inflate prosthesis 202, for exampleby placing at least one orifice 404 in tube 204. In some embodiments ofthe invention, the filler is air. Additionally, alternatively and/oroptionally, in some embodiments, the filler is a biodegradable and/orbiocompatible material and/or fluid. In some embodiments, thebiodegradable material and/or fluid is saline. In some embodiments ofthe invention, the filler is a gel and/or liquid. In an embodiment ofthe invention, tube 204 is provided with gripping protrusions 406 inorder to increase the contact surface between tube 204 and plug 402 andtherefore the force that may be applied to plug 402 when sealingprosthesis 202. In some embodiments of the invention, plug 402 is ovoidshaped, and/or has a shape such that plug's 402 loose end 408 is largerthan the attached end 410 so that, as described in more detail belowwith respect to FIGS. 4A-C, 5 and 7, plug 402 seals inflatableexpandable prosthesis 202 during implantation.

FIGS. 4A-C are cutaway side views showing the progression of removablyattaching prosthesis implantation and/or inflation device 200 andprosthesis 202, in accordance with an exemplary embodiment of theinvention. Referring to FIG. 4A, in some embodiments, a rigid ring 412is cast on and/or connected to tube 204 of prosthesis implantationand/or inflation device 200, in an embodiment of the invention. In anembodiment of the invention, rigid ring 412 fits snugly onto tube 204such that air and/or other fluid injected into prosthesis 202 does notescape via the intersection of rigid ring 412 and tube 204, however tube204 is slidable in relation to rigid ring 412. This slidability is used,for example, when prosthesis implantation and/or inflation device 200 isseparated from prosthesis 202 in accordance with an exemplary embodimentof the invention. In an exemplary embodiment of the invention, plug 402is cast on tube 204 such that gripping protrusions 406 grasp at least aportion of attached end 410 of plug 402, shown in FIG. 4B. Optionally,mold injection and/or dip molding, and/or any other method known in theart, may be used for manufacturing plug. At least tube 204 and/or plug402 and/or rigid ring 412 are made of biodegradable and/or biocompatiblematerials, in an embodiment of the invention.

In some embodiments, rigid ring 412 is cast on or connected to tube 204before plug 402 is cast tube 204 because in an exemplary embodiment ofthe invention, plug 402 has a larger diameter than the inner diameter ofrigid ring 412 thereby preventing plug 402 from passing through rigidring 412. In an embodiment of the invention, inflatable expandableprosthesis 202 is placed around plug 402 and tube 204 such that tube 204and plug 402 extend into a cavity proscribed by prosthesis 202.Prosthesis 202 is attached to an exterior surface of rigid ring 412 suchthat air and/or other fluid injected into prosthesis 202 does not escapevia the intersection of prosthesis 202 and rigid ring 412, in anembodiment of the invention. Optionally, a thermal and/or chemicalmethod is used to attach prosthesis 202 to rigid ring 412.

FIG. 5 shows an assembly 500 including a portion 502 of inflation device200 and a portion 504 of expandable prosthesis 202 further comprising acounterforce ring 506, in accordance with an exemplary embodiment of theinvention. In an embodiment of the invention, counterforce ring 506 isadapted to apply counterforce to rigid ring 412 during separation ofprosthesis inflation device 200 from prosthesis 202, as described inmore detail below with respect to FIG. 7. In some embodiments of theinvention, counterforce ring 506 is constructed of a biocompatiblematerial, for example stainless steel and/or plastic, that isapproximately at least as hard as rigid ring 412.

In some embodiments of the invention, at least one pressure regulatingvalve 600, shown in FIG. 6, is used in addition to or alternatively toplug 402 and rigid ring 412 for sealing prosthesis 202 after at leastpartially inflating prosthesis 202 with prosthesis implantation and/orinflation device 200. In some embodiments, pressure regulating valve 600release of filler based on a predetermined and/or pre-set pressure inthe prosthesis 202. In some embodiments, pressure regulating valve 600allows unhindered inflation but allows deflation based on apredetermined pressure inside prosthesis 202. In some embodiments, themaximal inflation volume is between 5 to 100 cubic centimeters (cc),optionally 10 to 60 cc, optionally 15 to 45 cc, or higher, or lower, orintermediate. In some embodiments, the final (partially inflated) volumeis between 0.5 to 60 cc, optionally 5 to 40 cc, optionally 9 to 30 co,or higher, or lower or intermediate. In some embodiments, inflating theimplant by adding a first amount of filler causes the implant to fullyexpand, fully unroll, and/or expand a void to a predetermined shapeand/or size.

In some embodiments, pressure regulating valve 600 is deployed foreffective operability at a certain/chosen interval during implantation,deploying and/or setting up of prosthesis 202 at the hostingenvironment. In some embodiments, pressure regulating valve 600 is setto operate after inflating prosthesis 202 to a maximal or otherwisechosen value. In some embodiments, pressure regulating valve 600 allowsfiller to be released out until pressure in prosthesis 202 goes down toa chosen value, e.g., a maximally allowed pressure. In some embodiments,the pressure regulating valve 600 allows filler to be released into avoid space in the joint. This is achievable, for example, if pressureregulating valve 600 is set to burst over a threshold value which may besame or slightly greater or smaller than the maximally allowed pressure.Certain external forces may be applied, either passively by a physicianand/or actively by the patient, for example forces exerted bymaneuvering the hosting environment (e.g., the joint or an adjoinedarm), to thereby expel out from prosthesis 202. After utilizing pressureregulating valve 600, in some embodiments, it may then be neutralized ordiscarded and/or prosthesis 202 may be sealed.

In some embodiments, the pressure regulating valve 600 is attached tothe prosthesis. In some embodiments, the pressure regulating valve isexternal from the implant. In some embodiments, the pressure regulatingvalve 600 is biodegradable and/or biocompatible. In some embodiments,the valve 600 is manufactured from at least one biodegradable and/orbiocompatible synthetic material such as, but not limited to,polycaprolactone (“PCL”), polyglycolide (“PGA”), polyhydroxybutyrate(“PHB”), plastarch material, polyetheretherketone (“PEEK”), zein,polylactic acid (“PLA”), polydioxanone (“PDO’), poly(lactic-co-glycolicacid) (“PLGA”), poly(lactice acid-co-epsilon caprolactone) or anycombination and/or family members thereof. In some exemplary embodimentsof the invention, the valve is manufactured from at least one“naturally-derived” biodegradable and/or biocompatible materials such ascollagen and/or methyl cellulose.

In some exemplary embodiments of the invention, valve 600 isnon-biodegradable. Non-biodegradable valves 600 are manufactured ofbiocompatible materials such as polyethylene, Kevlar®(poly-paraphenylene terephthalamide), polyurethane or silicon, or anycombination thereof, in some embodiments of the invention. In someexemplary embodiments of the invention, the valve 600 is manufacturedfrom biologically derived, biocompatible and/or biodegradable materialssuch as collagen.

FIG. 3 shows an anatomical view of a human shoulder 300 with anexpandable prosthesis 100, 202 in vivo, in accordance with an exemplaryembodiment of the invention. Prosthesis 100, 202 is inserted between theacromion 302 and the coracoid process 304, in an embodiment of theinvention. In some embodiments of the invention, prosthesis 100, 202 andany other prosthesis described herein, is inserted proximal to the bursa306. Optionally, if there is no bursa 306 of any remarkable size, theprosthesis is inserted in lieu of bursa 306. In an embodiment of theinvention, an implanted prosthesis, such as those described herein, isadapted to cover the humerus head during shoulder 300 motion, whileremaining relatively fixed in relation to the acromion 302 and/or thecoracoid process 304.

In some embodiments of the invention, an anchoring expandable prosthesisis adapted to prevent and/or reduce injury to the rotator cuff and/or topermit relatively unhindered or free shoulder movement, for example ifthe rotator cuff soft tissues are partially or completely torn and/ordeteriorated. In some embodiments, the anchoring expandable prosthesiscomprises an expandable member and at least one anchoring device whichis adapted to be attached to a part of the patient, for example thehumerus head/tendons, acromion and/or coracoid process, therebyanchoring the prosthesis in place. In an embodiment of the invention,the anchoring expandable prosthesis comprises at least one anchoringdevice attached to an expandable portion adapted to operate similarly toprostheses 100, 202. The at least one anchoring device is manufacturedof biocompatible and/or biodegradable or non-biodegradable metals and/oralloys and/or composites, for example titanium, stainless steel ormagnesium alloys. In an embodiment of the invention, the expandableportion is manufactured of biocompatible and/or biodegradable ornon-biodegradable materials such as high density polyethylene or thosedescribed with respect to prostheses 100, 202. In an embodiment of theinvention, the at least one anchoring device is attached to theexpandable member using filaments and/or wires.

In some embodiments of the invention, prostheses described herein areadapted for anchoring, for example by contouring the outer surface suchthat surrounding tissues can be placed within the contours, thereby“anchoring” the device. In some embodiments of the invention, thecontours are adapted to act as counterparts to anatomical features atthe implantation site, whereby the features settle into the contoursupon implantation, but still permit relatively unhindered movement ofthe treated area.

Alternatively, in some embodiments, the prostheses 100, 202 do notinclude anchoring and kept in place and/or be allowed to partial and/orlimited relative movement with a tissue in contact due to shapecorrelation in the void maintained by peripheries of adjacent tissues.In some embodiments, prostheses 100, 202 are adapted for moving in alimited range of motion, optionally reflecting changes in surroundingboundaries due to joint movement. Such movements may alternatively oradditionally derive from shifting between static to kinetic dry frictionforces created between a surface of a prosthesis in contact with amoving tissue. In some embodiments, the prosthesis is selectivelychanged to impose a chosen maximal friction characteristic (e.g., amaximally allowed static friction force between a surface and a specifictissue type in contact), for example a friction coefficient and/or anormal force applied to the tissue in contact.

In some embodiments, prostheses 100, 202 are shaped, internallypressurized and/or inflated/deflated to a degree which maintains orfacilitates, optionally in an allowed range of motion, a stableequilibrium in which the prosthesis will restore a nominal position whenthe joint returns to a non- of a less-stressed position and/or when thevoid substantially returns to a nominal shape and/or size, such as ashape and/or size during prosthesis implantation. Alternatively oradditionally, prostheses 100, 202 are shaped, internally pressurizedand/or inflated/deflated to a maximal predetermined or patient-specificsize (e.g., a height); optionally while substantially not changing otherdimensions (e.g., width and/or thickness), thereby avoiding potentialdislocations due to tissue (e.g., bony tissues) movements in the void.For example, an acromion portion may enter and/or decrease the height ofthe void (in this example: the subacromial space or portion thereof)during a shoulder movement (e.g., flexion and/or extension/externalrotation) so if the prosthesis is inflated to a height greater than thevoid's decreased height, it may be forced by the acromion portion todislocate; optionally out of the allowed range of motion and/or to anunstable equilibrium in an embodiment of the invention.

As mentioned above, prostheses 100, 202, and/or any of the otherprostheses described herein, may be designed for use in places wherethere is sliding of soft tissues or other tissues, such as tendonsagainst other tissues, such as bones as: a) between the quadriceps andfemur after operations on the knee, b) near the finger flexor and/orextensor to prevent adhesions, for treatment of ailments such as carpaltunnel syndrome and/or, c) between the skin and plantar fascia andcalcaneus in case of calcaneal spur, in some exemplary embodiments ofthe invention. As described above, the prosthesis used for treatment ofparticular ailments is sized and/or shaped to simulate the natural bursafound at the location being treated, in an exemplary embodiment of theinvention, in some embodiments, same or different slidingcharacteristics facilitated by the prostheses of the present inventionallow relative motion between hard tissue types, such as cartilagesand/or bones, for example when tendons and ligaments are completelytorn.

In an embodiment of the invention, an expandable prosthesis which is atleast slightly elastic, but not inflatable, is designed to permitrelatively unhindered or free shoulder movement. In some embodiments ofthe invention, the elastic prosthesis is manufactured from polyethyleneand/or silicon and/or in combination with metals, such as titanium.Optionally, the elastic prosthesis is contoured to serve as acounterpart to the surfaces with which it will come into contact. Forexample in the case of a rotator cult; the elastic prosthesis may becontoured to fit at least the acromion.

In an embodiment of the invention, a prosthesis is provided which issubstantially rigid. The rigid prosthesis is constructed of abiocompatible material, for example stainless steel and/or a hardplastic: in some embodiments of the invention. Optionally, in someembodiments, the rigid prosthesis is also biodegradable. In someembodiments of the invention, the rigid prosthesis is adapted to act asa counterpart to at least one anatomical feature at the implantationsite, whereby the feature mates with the rigid prosthesis uponimplantation, but still permits relatively unhindered movement of thetreated area. As an example, the rigid prosthesis is adapted to matewith both the humerus head and the acromion upon implantation, in anembodiment of the invention.

Referring to FIG. 7A, a method 700 of implanting an expandableprosthesis 100, 202, or any other prosthesis described herein isdescribed, in some exemplary embodiments of the invention. In anembodiment of the invention, implantation method 700 is adapted forimplantation of prostheses 100, 202, or any other prosthesis describedherein, into the shoulder of a patient to prevent and/or reduce injuryto the rotator cuff and/or to permit relatively unhindered or freeshoulder movement. In an embodiment of the invention, prostheses 100,202, or any other prosthesis described herein, are introducedpercutaneously or by making (702) a small incision, optionally performedby posterior, lateral or anterior approaches using, for example,palpation, arthroscopy, ultrasound (“US”), computed tomography (“CT”),magnetic resonance imaging (“MRI”), fluoroscopy, transmission scan(“TX”), or any combination thereof. In an embodiment of the invention, aneedle is inserted (704) into the void space between the rotator cufftendons and the acromion 302 and coracoid process 304. A guide wire isintroduced (706) via the needle into the void space between the rotatorcuff tendons and the acromion 302 and coracoid process 304, in anexemplary embodiment of the invention. In some embodiments of theinvention, a dilator is placed (708) over the guide wire and extendedinto the space. Subsequently, a trocar of the dilator is removed (710),leaving a dilator sheath in place in some embodiments.

In an embodiment of the invention, inflatable expandable prosthesis 202is placed (712) into the void space using the dilator sheath and/or theprosthesis inflation device 200 for guidance and/or movement impetus.Once prosthesis 202 is approximately in the proper position, in someembodiments, the dilator sheath and an external sheath 802 of prosthesisinflation device 200, shown and described in more detail with respect toFIG. 8, are withdrawn (714) to allow for inflation (716) of prosthesis202. Inflation (716) using prosthesis inflation device 200 is describedin more detail below. Inflation (716) of prosthesis 202 is achieved, insome embodiments of the invention, during arthroscopy. In someembodiments of the invention, for example if prosthesis 202 is implantedduring open surgery or arthroscopy, proper deployment of prosthesis 202is ascertained by visual inspection of prosthesis 202. In an embodimentusing arthroscopy, prosthesis may be introduced through an arthroscopyport. In some embodiments of the invention, inflation (716) is achievedusing palpation and US guidance to ascertain proper deployment ofprosthesis 202. In some embodiments of the invention, inflation (716) isachieved using fluoroscopy to ascertain proper deployment of prosthesis202. Proper deployment of prostheses, in some embodiments of theinvention, means no interposition of tendons and/or other soft tissuebetween the implanted prosthesis and acromion 302 or coracoid process304 and/or that during movement of the humerus, the prosthesis remainsbelow acromion 302.

Inflation (716) of prosthesis 202 is performed using prosthesisinflation device 200, in an embodiment of the invention. Referring toFIG. 8, an expandable prosthesis 202 is shown packed for implantationand prior to deployment, in accordance with an exemplary embodiment ofthe invention. Components of the assembly 800 are enclosed in anexternal sheath 802 which surrounds at least prosthesis 202, in anexemplary embodiment of the invention. External sheath 802 is adapted tomaintain prosthesis 202 in a collapsed condition during placing (712) inorder to ease insertion of prosthesis 202 into the implantation space orsite through the dilator sheath, in an embodiment of the invention. Asdescribed above, once prosthesis 202 is in the implantation space,external sheath 802 is removed, enabling prosthesis 202 to be inflatedwithout hindrance apart from the body parts against which prosthesis 202is pressing in an embodiment of the invention.

In an embodiment of the invention, inflation (716) of prosthesis 202 isperformed by adding a sufficient filler such as physiologic fluid suchas saline, Hartman or Ringer solutions and/or any other biocompatibleand/or biodegradable fluid. In some embodiments of the invention,inflation (716) is performed using a biocompatible and/or biodegradablegel. In an embodiment of the invention, inflation (716) of prosthesis202 is performed using a gas, for example air and/or carbon dioxide. Insome embodiments of the invention, the inflating gel and/or fluidcontains pharmaceutical agents, for example anti-inflammatory drugsand/or antibiotics and/or pro-angiogenesis factors to promote healing,which are eluted into the patient's body. In some embodiments of theinvention, prosthesis 202 is inflated to the maximum volume possiblewithout reducing the shoulder's range of movement. In an embodiment ofthe invention, prosthesis 202 is filled to less than its maximum volumein order to permit shifting of the contents of prosthesis 202 duringmovement. Optionally, in some embodiments, the prosthesis 202 is filledto 50%-70% of its maximal inflation volume (for example, an expandablemember with a 14 cc volume is filled with 9 cc of filler). It should benoted that other prosthesis embodiments described herein are deployed ina similar fashion, in some embodiments of the invention.

Sealing (718) of prosthesis 202, once inflated to the desired level, isperformed by pulling tube 204 towards rigid ring 412 as they slide inrelation to one another plug 402 becomes lodged in a lumen 804 of rigidring 412 and continued pulling brings rigid ring 412 into contact withcounterforce ring 506, in an embodiment of the invention. In anembodiment of the invention, tube 204 passes through lumen 804 withlumen 804 providing fluid communication between prosthesis implantationand/or inflation device 200 and an inner space defined by the dimensionsof prosthesis 202. In an embodiment of the invention, an attendingmedical professional performing the implantation procedure holdscounterforce ring 506 substantially steady while pulling on tube 204away from the patient. Optionally, in an embodiment, prosthesisinflation device 200 is adapted to perform the steadying of counterforcering 506 and/or retraction of tube 204 automatically. In someembodiments of the invention, a mechanism is provided to prosthesisinflation device 200 which translates rotational movement to aretracting force on tube 204. Optionally, rotation movement is appliedmanually.

Continued pulling (“retraction” away from patient) of tube 204 causes aportion of plug 402 to break off, the portion of plug 402 lodging itselfin lumen 804 of rigid ring 412 thereby sealing (718) prosthesis 202. Insome embodiments of the invention, the portion of plug 402 becomespartially deformed as it lodges in lumen 804. Prosthesis inflationdevice 200 (referred to as “implantation device” in the figure), nowbeing separated from prosthesis 202 as a result of sealing (718) iswithdrawn (720) from the patient and patient is closed, in an exemplaryembodiment of the invention. It should be understood that in someembodiments of the invention, a sponge-like expandable prosthesis deviceis used and therefore, inflation (716) and inflation related actions maynot be carried out, for example prosthesis 100 expands rather thaninflates.

In an exemplary embodiment of the invention, the implanted prosthesis issecured, using methods known in the art, to soft tissue and/or bone toprevent the prosthesis from being easily displaced by shoulder movement.In some embodiments of the invention, sutures, clips and/or anchors areused to secure the prosthesis in place. Optionally, an anchoringexpandable prosthesis is used. In an embodiment of the invention,simulating a naturally occurring bursa using a prosthesis is an actiontaken with respect to method 700. Optionally, simulating is related toinflation (716) in that the prosthesis is inflated to resemble theappropriate size and/or shape and/or characteristics (malleability,compressibility, etc.) of the naturally occurring bursa. In anembodiment of the invention, placing the prosthesis at the implantationsite and simulating a naturally occurring bursa does not significantlyreduce movement of the soft tissues being protected in relation to theother tissues at the implantation site.

In an exemplary embodiment of the invention, prosthesis 100 is implantedby placing prosthesis 100 into a cannula, such as those describedelsewhere herein, and advancing it to the implantation site using aplunger.

In an exemplary embodiment of the invention, prosthesis 100 or theelastic prosthesis, described above, is implanted by inserting thedevice directly through a small incision, without a cannula, near theimplantation site.

FIG. 7B shows a method for implanting prostheses 100, 202, or any otherprosthesis described herein according to another embodiment. In anembodiment, an incision is made (731) as known in the art and/or similarto step 702 above. Optionally, in some embodiments, a passage fromincision and/or an implantation space are created (732). Passage and/orimplantation space may be created (732) manually/digitally and/or byusing a dedicated instrument, such as a dilator in some embodiments.Alternatively, a passage and/or an implantation space are anatomicallyand/or readily present in some embodiments. Alternatively oradditionally, a passage to an anatomical space (e.g., a subacromialspace) is created (732) by pushing therethrough the prosthesis and/orany implantation/delivery apparatus in some embodiments. Once theimplantation site is located and/or prepared, as discussed above, asized prosthesis, such as any of prostheses 100, 202, or any otherprosthesis described herein, is introduced and placed (733) into theimplantation space in a collapsed and/or rolled form through theincision in some embodiments. In some embodiments, prostheses 100, 202,or any other prosthesis described herein is introduced (712) covered, atleast partially, with a protective sheath or a cannula, which is thenwithdrawn and removed (734). An outer diameter of the protective sheathmay be 10 mm or less, optionally 6 mm or less in some embodiments. Insome embodiments, the prosthesis and/or protective sheath and/orintroducer is inserted with or followed by a camera or any other imagingdevice.

The prosthesis is then inflated (735), for example by adding asufficient amount of filler such as saline thereto, for example asdescribed above as with respect to step 716. In some embodiments, theprosthesis is filled with a sufficient amount of filler X to or over apredetermined or a chosen degree, optionally to over 70% of its maximalinflation volume, optionally 90-100% of its maximal inflation volume. Insome embodiments, the prosthesis is then deflated by releasing an amountof filler Y from the implant to a lesser degree, optionally to a finalchosen characteristic (e.g., a volume and/or consistency), optionally toless than 70% of its maximum volume, optionally 50-70%, optionally toless than 50% its maximal inflation volume.

In some embodiments, the ratio of X:Y is less than or equal to 10:1. Insome embodiments, the ratio of X:Y is less than or equal to 7:1. In someembodiments; the ratio of X:Y is less than or equal to 4:1. In someembodiments, the ratio of X:Y is less than or equal to 2:1. In someembodiments, the ratio of X:Y is less than or equal to 1.5:1. In someembodiments, the ratio of X:Y is less than or equal to 1.3:1. In someembodiments, the ratio of X:Y is less than or equal to 1.2:1. In someembodiments, the ratio of X:Y is less than or equal to 1.1:1.

In some embodiments, deflation occurs by using inflation device 200 (orany other fluid passing means) in a reverse mode. Alternatively oradditionally, in some embodiments, pressure regulator means are deployed(736), such as pressure regulating valve 600, allowing filler expulsionor release when the prosthesis is pressurized to over a predeterminedpressure such as by articulation of a joint. In some embodiments, thepressure regulating valve 600 is preset to burst at or over a thresholdpressure of 1 psi, optionally at or over about 5 psi, optionally at orover 8 psi, optionally at or over 12 psi, optionally at or over 20 psi.

In some embodiments, actual deflation occurs by applying (737) externalforces to the fully expanded prosthesis via its surrounding environment(e.g., tissues surrounding and/or supporting the implantation spaceand/or engage with the prosthesis). In some embodiments, external forcesare applied by articulating the shoulder joint or moving the shoulder ina chosen range of motion (ROM) scenario, in a manner that contracts theprosthesis and increases its internal pressure. Such ROM may include aset of maneuvers, some of which may instantly build pressures peakswhich are over the predetermined pressure, thereby allowing fillerrelease through pressure regulating valve 600 until the prosthesis innerpressure decreases to under the threshold pressure. The ROMs may bepassive in the sense that no intentional or unintentional patientrelated force and/or muscle tone is actively present but only maneuversperforms by the physician when the patient is anesthetized. In someembodiments, such deflation scheme may be used as the prosthesis ispatient-specific calibrated. After prosthesis adjustment, pressureregulating valve 600 is neutralized, deactivated or removed and theprosthesis is sealed (738) in some embodiments. Inflation device 200 isthen withdrawn and the incision is closed (739) as known in the artand/or as with respect to step 720 above in some embodiments.

It should be noted that the methods shown and described with respect toFIGS. 7A-B are by way of example only, and that similar methods could beused for implantation of any bursa simulating prosthesis designed foruse between soft tissues and other tissues of the body.

FIG. 7C shows a diagram 740 which is purely schematic and illustrative,demonstrating a pressure-change graph 742 of a prosthesis, such asprostheses 100, 202, or any other regulating valve 600, and that isreadily implanted using method 730. Graph 742 is presented versusequivalent graphs of identical prostheses being inflated to a chosendegree with no prosthesis and graph 746 of an under-inflated prosthesis.The horizontal axis is set according to the variable ROM maneuvers whichmay be present as a sequence of prosthesis pressurizations in time, andis referred to as “ROM.” The vertical axis presents the variablepressure P that is built in the prostheses in view of the variable ROM.As shown, all graphs include several pressure peaks which present suddenincreases of inner pressure due to maximal decrease in volume of thesealed prostheses. Certain movements, e.g., max flexion or extension,may cause highest pressure peaks, although this may be mostly dependenton other patient-specific factors such as the prosthesis surroundingenvironment (e.g., its consistency, geometry and/or size) and/or itsengagement with the prosthesis periphery (e.g., slight over-sizing orunder-sizing at nominal positioning, etc.). Graph 742 includes max peakswhich stop at (or otherwise be only less than) a maximally allowedpressure P_(max) which was set during ROM scenario at step 737 inprosthesis implantation method 730 using valve 600 preset with athreshold pressure substantially same or similar to P_(max). Graph 744shows the pressurization curve of the over-inflated prosthesis under ROMhaving two peaks which are over the maximally allowed pressure P_(max).At such pressure peaks, the prosthesis is prone to be compressed and/orcontracted to such a degree where its two confronting walls may be tooclose and even in-contact, an undesired possibility which may causepain, illness and/or prosthesis failure and malfunction. Moreover, theaverage inner pressure, including a minimal pressure substantially overP_(min), suggests that the prosthesis is substantially stiffer thandesired and therefore may be prone to migrate on certain jointmovements. Therefore application of pressure regulating means may easeand/or facilitate boundaries for any expected generated pressure,prosthesis compression and/or possible migration. Graph 746 shows thepressurization curve of the under-inflated prosthesis under ROM:although having no peak which crosses or even come close to maximallyallowed pressure P_(max), it is prone to instances in which innerpressure will be less than a minimal value P_(min), especially when noexternal forces are applied thereto. This way, the prosthesis may notfunction properly as a spacer, sliding surface and/or a cushion and mayeven be prone to unstable equilibrium by which certain movements willcause it to permanently shift out of place. This emphasizes an advantageof first inflating the prosthesis to a certain degree higher than achosen threshold value, and even providing pressure regulating means.

FIG. 9 is a perspective view of a device 1200 in accordance with anexemplary embodiment of the invention. In an embodiment of theinvention, device 1200 is a sponge-like device 1200 is adapted to beplaced at a site in the body for treating inflammation and/or infection,in an embodiment of the invention.

In an exemplary embodiment of the invention, a sponge-like device 1200is manufactured of biocompatible and/or biodegradable syntheticmaterials such as, but not limited to, PLA, PLGA, PCL, PDO, poly(lacticeacid-co-epsilon caprolactone) or any combination thereof. Alternativelyand/or additionally and/or optionally, in some embodiments, thesponge-like device 1200 may be manufactured from biologically derivedbiodegradable materials such as collagen. Expandable sponge-like device1200 optionally contains within its cavities at least one biocompatibleand/or biodegradable gelling material, such as methyl cellulose,agarose, poly(ethylene-glycol) (“PEG”) gel and/or PLA gel, that expandswhen it comes into contact with at least one bodily fluid, for exampleby absorbing water. In an embodiment of the invention, such absorptionis partly responsible for an expansion of sponge-like device 1200 intoits intended deployed position.

As described above, in some exemplary embodiments of the invention,device 1200 comprises an inflatable structure. In an embodiment of theinvention, inflatable device 1200 is constructed of at least onebiocompatible and/or biodegradable material, such as those describedherein. In some embodiments of the invention, inflatable device 1200 isspherical or cylindrical, having a diameter of 0.5 cm to 5 cm for asphere or in the long direction (x-axis) and 0.5 cm to 4 cm in the shortdirection (y-axis) and a height (z-axis) of 0.5 mm to 20 mm. In someembodiments of the invention, device 1200 is adapted to be inserteddeflated into a patient's body through a cannula. Optionally, thecannula is a 5 mm-7 mm cannula. Optionally, device 1200 dimensions areadapted for a particular intended use.

In some exemplary embodiments, device 1200 is inflated and/or implantedas described herein with respect to prostheses 100 and 202. Device 1200optionally contains pharmaceutical agents, for example anti-inflammatorydrugs and/or antibiotics and/or pro-angiogenesis factors to promotehealing, which are eluted into the body. In some embodiments of theinvention, device 1200 is adapted to elute pharmaceutical agentsaccording to a predefined schedule. Adaptation of device 1200 includesconstruction of device 1200 using materials or combinations of materialswhich degrade at a predetermined rate, thereby releasing pharmaceuticalagents contained therein at a predetermined rate. In an exemplaryembodiment of the invention, more than one device 1200 is used fortreating inflammation and/or infection. Optionally, each device isadapted to elute pharmaceutical agents in view of an overall planincorporating a plurality of devices.

In another exemplary embodiment of the invention, an expandable device,such as those described herein, is adapted to be used near anarticulation to reinforce the articular capsule. In an embodiment of theinvention, the expandable device is introduced in anterior fashion tothe shoulder articulation between the articular capsule and the deltoidand pectoralis muscle, in order to prevent recurrent dislocation of theshoulder. In another embodiment, the expandable device is introduced infront of the hip joint capsule to prevent anterior dislocation of thehip, especially in cases of congenital dysplasia of hip. In an exemplaryembodiment of the invention, the expandable device consists of ininflatable member made of biocompatible and/or biodegradable material.In some embodiments of the invention, the expandable device has adiameter of 1 cm to 10 cm in the long direction (x-axis) and 1 cm to 9cm in the short direction (y-axis) with a height (z-axis) of 0.5 mm to25 mm. Optionally, the device has a height of 3 mm to 15 mm.

Reference is now made to FIG. 10 which shows an isometric view of aprosthesis implantation and/or inflation device 2000 readily connectedto an inflatable expandable prosthesis 2100, in accordance with anexemplary embodiment of the invention.

Prosthesis 2100 which is shown fully expanded may be any of thepreviously described prostheses or may include at least onecharacteristic thereof, in some embodiments, prosthesis 2100 is aninflatable implant adapted to reach, at a maximal or over apredetermined partial inflation volume, a disc like shape as shown inFIG. 10. As shown, the disc shape generally includes two at leastpartially parallel and substantially flat, oval surfaces, which aredistant one to the other by a relatively small width, and a peripheral,optionally rounded wall connecting the surfaces while allowing a singleport for inflation-deflation. In some embodiments, prosthesis 2100 ismanufactured as a single piece, optionally seamless. In someembodiments, prosthesis 2100 consists essentially of a biodegradablematerial, optionally of a homogenously created wall. In someembodiments, at least one of the flat oval surfaces are smooth enough toallow or even facilitate a continuous unhindered sliding thereon of atissue in contact, such as a ligament, a tendon, a cartilage or a bone.

In some embodiments, prosthesis 2100 is mounted on a needle 2200 usingdetachable connection means. Prosthesis 2100 is provided completelydeflated and rolled or otherwise collapsed to a small volume for aminimally invasive delivery, while covered, protected and maintained incollapsed form by a sheath 2300. Once in place and before inflation,sheath 2300 is withdrawn thereby allowing prosthesis 2100 to unroll andexpand. In some embodiments, during inflation, prosthesis 2100 firstunrolls, and only during or after complete unrolling, it begins toexpand in width until reaching a fully or predetermine inflated shape orsize, for example as shown in FIG. 10.

In some embodiments, prosthesis implantation and/or inflation device2000 further includes a handheld operator 2400 comprising of housing2410 ergonomically designed for manual manipulation of needle 2200 andthe connected prosthesis 2100 in patient's body.

Operator 2400 includes a knob 2440 that is clock-wise rotatable from afirst closed position until a fully opened position, while rotating atubular stopper 2460 connected thereto over a proximal portion of needle2200. In some embodiments, needle 2200 includes locking means (notshown) to prosthesis 2100 that are selectively released when stopper2460 revolves to a partial or full opened position of knob 2440.Alternatively or additionally, clock-wise rotation of knob 2440 promotesaxial movement of needle 2200 within tubular stopper 2460 away fromprosthesis 2100 until detachment. Optionally, a proximal axial movementfurther promotes sealing of prosthesis port by forcefully pulling a sealtherein. In some embodiments, rotation of knob 2440 is selectivelyallowed or prevented using safety 2430.

An operator port 2450 located optionally at a proximal end of housing2410 is connectable to an external inflation medium reservoir and/orpressurizing device, such as a pump or a syringe (not shown). Inflationmedium is preferably a fluid (e.g., saline) which is transferable fromthe external reservoir through a lumen in housing 2410, needle 2200 andinto prosthesis 2100.

Needle 2200 and/or stopper 2460 can be made of any biocompatible rigidor semi-rigid material, such as but not limited to metals (e.g.,stainless steel). Housing 2410 and other parts affixed thereto can bemade of plastic or other polymers such as Polycarbonate, Any of thedisclosed parts and elements may be disposable or non-disposable andmeant for single or multiple use.

In some embodiments, operator 2400 includes connecting means 2420 toauxiliary devices or instruments, such as a pressure meter, atemperature meter and/or a flow rate meter.

In an exemplary embodiment of the invention, an expandable prosthesis isintroduced in a glenohumeral joint capsule between the humerus andglenoid cartilage surfaces, and/or in a subacromial space between ahumerus portion and an acromion portion, to prevent injury thereof, orother joint related illness, and/or to permit relatively unhindered orfree shoulder movement. Optionally, alternatively and/or additionally,an expandable prosthesis comprises an inflatable structure and asponge-like structure in combination.

FIG. 11 is a cutaway view of inflatable expandable prosthesis 3000deployed in a glenohumeral joint capsule, in accordance with anexemplary embodiment of the invention. In some embodiments, a firstsurface of prosthesis 3000 is at least occasionally and/or partially incontact with an external surface of a cartilage portion of the humerushead/ball. Alternatively or additionally, a second surface of prosthesis3000 is at least occasionally and/or partially in contact with anexternal surface of a glenoid cartilage portion and or with the labrum,in some embodiments, at least one surface of prosthesis 3000 is smoothand allows gliding and/or frictionless motion of a cartilage portion incontact. Alternatively or additionally, at least one surface is coarseand/or comprising a frictional element (e.g., a mesh) thereby avoidingrelative motion with respect to a cartilage portion in contact.

In some embodiments, prosthesis 3000 is configured to change its overallconsistency to a specific chosen degree. “Consistency” will beconsidered herein as any property or combination of properties thatdirectly relate to the prosthesis ability to hold and retain itsoriginal shape. Consistency may be the element density, softness,firmness, viscosity or any combination thereof. Prosthesis 3000consistency may be altered by the degree of relative inflation (vol. ofactual inflation medium divided by vol. in maximal inflation) and/or bythe properties (e.g., viscosity) of the inflation medium. In someembodiments, prosthesis 3000 is deployed in a consistency that issimilar, identical or equivalent to that of a synovial membrane orsynovium, optionally the ones of the glenohumeral joint. It should benoted that a viscosity of normal synovial fluid is about 1 to 2 inchstring (using a string test model: the max stretchable length of ameasured fluid drop). Alternatively, the physician may choose anotherconsistency according to need, which may or may not resemble aconsistency of a cartilage or a bone.

In some embodiments, prosthesis 3000 is fully inflated so it may beapplied to firmly occupy a space, be uncompressible under unyieldingforces and/or separate away the two adjacent joint surfaces, in someembodiments, prosthesis 3000 is not fully inflated at end of procedureso it is compressible under inward pressures. In some embodiments, aninflation device and/or prosthesis 3000 are configured and equipped toallow selective inflation/deflation and/or adjustments to a chosenvolume and/or relative inflation. In some embodiments, prosthesis 3000is filled with a filler such as a Newtonian fluid (e.g., water orsaline). Alternatively or additionally, the filler includes anon-Newtonian fluid (e.g., hyaluronic acid) having a determined and/orvariable viscosity. Alternatively or additionally, the inflation mediumincludes a lubricating material, either fluidic or non-fluidic,optionally a non-polar fluid such as lipid or oil. In some embodiments,only a minute quantity of material is introduced into prosthesis 3000inner volume, optionally inefficient as to promote expansion, but stillimproves frictionless motion capabilities of prosthesis 3000 innersurfaces one with respect to the other. In some embodiments, prosthesis3000 wall is sized and configured to have a chosen consistency wheninflated partially and/or fully, optionally by combining specific wallthickness and wall material.

Reference is now made to FIGS. 12A-C which show schematic cut views ofprostheses 4000A, 4000B and 4000C, and portions of implantation and/orinflation devices 4300A, 4300B and 4300C, respectively, furthercomprising pressure regulating valves 4200A, 4200B and 4200C,respectively, at different locations, in accordance with an exemplaryembodiment of the invention. The pressure regulating valves are in someembodiments preset or designed to burst or open at a predeterminedpressure that is built inside the prostheses. In FIG. 12A, valve 4200Ais affixed to a distal end of inflation device 4300A and is releasablyattachable to a port of prosthesis 4100A or adjacent releasablyattachable connection means on the inflation device. In FIG. 12B, valve4200B is affixed to a proximal portion of prosthesis 4100B and isreleasably attachable to a distal end of inflation device 4300B oradjacent a releasably attachable connection means of the prosthesis. Insome embodiments, valve 4200B is made of same materials as prosthesis4100B and/or is biodegradable. In FIG. 12C, valve 4200C is affixed alongthe length or at a proximal end of inflation device 4300C and isrelatively remote from prosthesis 4100C.

FIGS. 13A-E are schematic cutaway views and an isometric viewillustrating deployment stages of prosthesis 4000A between two adjacentjoint related tissues, in accordance with an exemplary embodiment of theinvention. In some embodiments, the two joint related tissues surround asubacromial space and may include for example ligaments or tendons of arotator cuff, and/or a humerus, an acromion or a coracoid process. Inother embodiments, the two adjacent joint related tissues are bone orcartilage tissues of a synovial joint, for example a humerus tissue anda glenoid tissue in a glenohumeral joint capsule. The following stepswill be devoted for subacromial space prosthesis implantation fordemonstrative purpose.

In some embodiments, the implant includes a first face and an opposingsecond face. In some embodiments, the articulation of the joint resultsin a predetermined distance between the first face and the opposingsecond face of the implant. In some embodiments, the predetermineddistance between the first face and the opposing second face of theimplant is the first face and the opposing second face of the implant isgreater than 0.1 mm, greater than 0.5 mm or greater than 1 mm. In someembodiments, the predetermined distance between the first face and theopposing second face of the implant is sufficient so that the first faceand the opposing second face do not touch each other and/or allowunhindered movement there between.

In some embodiments, the predetermined distance between the first faceand the opposing second face is a predetermined minimal distance. Insome embodiments, the predetermined minimal distance is selected in vivoand/or based on parameters specific to each patient. In someembodiments, the parameters specific to each patient include a maximumpressure reached during ROM. In some embodiments, the maximum pressurereached during ROM is equal to or greater than 1 psi, optionally equalto or greater than 5 psi, optionally equal to or greater than 8 psi,optionally equal to or greater than 12 psi, and/or optionally equal toor greater than 20 psi.

In some embodiments, prior to implantation some patient preparations areperformed, for example providing of anxiety reducing medication and/orprophylactic broad spectrum antibiotics. Patient may then be positionedas needed in shoulder surgeries, and surgical procedure begins byfirstly accessing the subacromial space using relevant surgicalinstrumentation (not shown).

Following the routine operational steps measurements of the patient'sspecific subacromial space are taken, as schematically illustrated inFIG. 13A, for example with a measurement probe such as those which areroutinely used in orthopedic surgeries. In some embodiments, themeasurements are taken through a true lateral port and optionallyinclude the distance between the lateral Acromion periphery to thesuperior Glenoid rim.

In some embodiments, a kit comprising a plurality of inflatableprostheses that are differentiated sizes is provided, allowing thesurgeon improve fitting to different spaces sized. In some embodiments,the surgeon uses certain correlative keys between subacromial spacemeasurements and provided prostheses sizes, for example: for anacromion-glenoid distance smaller than 5.5 cm, the surgeon is requestedto use a “small” sized balloon (for example, having a length ofapproximately 5 cm or less), for a distance between 5.5 and 6.5 cm, thesurgeon is requested to use a “medium” sized prosthesis (for example, alength of approximately 6 cm) and for distance over 6.5 cm the surgeonis requested to a “large” sized prosthesis (for example, a length ofapproximately 7 cm).

In some embodiments, before or after measurements, the anatomical areaof the subacromial space is debrided to a level that enables or improvesdevice implantation. Alternatively or additionally, subacromial space isforcefully increased, for example by pulling away the joint members at acertain direction (as schematically designated by a two sided arrow inFIG. 13B). Alternatively, no change is made to subacromial space sizeprior to implantation of prosthesis 4000A.

In some embodiments, prior to implantation, prosthesis 4000A ismoderately heated and for example is immersed in warm (optionally about40 degrees Celsius), sterile water thereby becoming more compliant todeployment at bodily temperatures.

As shown in FIG. 13B, the surgeon then picks a chosen sized prosthesis,in this example prosthesis 4000A, which is provided connected to adelivery and/or inflation device (shown is only a portion thereof).Prosthesis 4000A is inserted through an access port or directly—in easeof mini-open and open procedures. In some embodiments, prosthesis 4000Ais delivered through a minimally invasive created passage, for examplehaving a cross section diameter of approximately 3 mm or less, thereforeis provided fully deflated and collapsed to a small enough size. FIG.13C shows a partial isometric view of prosthesis 4000A with an exemplarynon-binding collapsed form, suggesting a double inward rolling of twoopposing prosthesis ends, optionally rolled in opposite directions. Insome embodiments, the collapsed prosthesis is delivered enclosed in adedicated sheath (not shown) which is withdrawn and removed from sitewhen prosthesis 4000A is properly positioned in the subacromial space.

Next, a syringe prefilled with a sterile saline solution is coupled tothe inflation device (not shown) in some embodiments of the invention.In some embodiments, a specific amount of saline is filled and/or isdelivered, for example as indicated on the chosen sized prosthesis,optionally by a marking or a label. In some embodiments, prior tosyringe filling or prior to delivery, the saline is warmed toapproximately 40° C.

As shown in FIG. 13D, prosthesis 4000A is then inflated to minimal sizeneeded for a full unrolling, optionally to a maximal size and/or amaximally allowed size. Optionally, prosthesis 4000A is inflated untilsubstantially or completely filling the subacromial space, either atrest position (for example when in normal rest size) or at extendedposition (for example when joint members are forcefully pulled apart).In some embodiments, the prosthesis 4000A is inflated sufficiently tocontact at least one surface of the tissue inside the joint orsubacromial space. Alternatively, prosthesis 4000A is inflated to anoversized expanded shape which presses or even forcefully increases thesubacromial space.

In some embodiments, and as shown in FIG. 13E, prosthesis 4000A isdeflated to a smaller size until a requested parameter is met, such asprosthesis internal volume, internal pressure, overall consistency,cushioning degree or another. In some embodiments, deflation isselectively performed. In some embodiment, deflation is performed byactively withdrawing the inflation medium from prosthesis 4000Ainterior. Alternatively or additionally, deflation occurs passively oractively due to compression forces applied by the two opposing tissues,for example when joint parts falls back into normal position or whendeliberate joint movements are done. In some embodiments, deflation isachieved by performing passive (partial or full) range of motion (ROM)of the shoulder. Such ROMs may include at least one of a forwardflexion, an abduction, an external rotation, an internal rotation and/ora cross-body adduction. The ROMs may include series of motions inclockwise and/or counterclockwise directions and may include but not belimited to any of the motions specified above in some embodiments. Insome embodiments, deflation occurs actively by withdrawing solution fromthe prosthesis up to 60-70% the maximal volume (when optionally, afinal/optimal volume is confirmed by performing smooth ROM maneuvers).

In some embodiments, prosthesis 4000A is deflated to a chosen internalpressure, optionally predetermined, which may be between 1 and 100 psi,optionally between 1 and 20 psi, optionally between 5 and 10 psi,optionally about 8 psi, or higher, or lower, or any intermediate value.Such deflation may be actively performed, for example by using thesyringe in a reverse mode. Alternatively, a pressure regulating valve,which may or may not be unidirectional and settable to deflation, can bepreset to burst over a chosen internal pressure. Such a pressureregulating valve may be set either by the prosthesis manufacturer and/orbe selectively set by an operator before or during the medicalintervention to a predetermined or to a patient-specific value. In someembodiments, the pressure regulating valve may be set to burst at apressure or at any chosen margin thereof which is equal or associatedwith a maximal internal pressure which develops in the prosthesis whenthe treated shoulder is articulated or performs a chosen ROM.

When reaching a chosen volume and/or pressure, the surgeon then operatesthe prosthesis and/or delivery device to seal the inflation port ofprosthesis 4000A and detach it from the inflation device. Alternativelyor additionally deflation is done after prosthesis detachment, forexample by performing a full ROM maneuver.

The present invention has been described using detailed descriptions ofembodiments thereof that are provided by way of example and are notintended to limit the scope of the invention. The described embodimentscomprise different features, not all of which are required in allembodiments of the invention. Some embodiments of the present inventionutilize only some of the features or possible combinations of thefeatures. Variations of embodiments of the present invention that aredescribed and embodiments of the present invention comprising differentcombinations of features noted in the described embodiments will occurto persons of the art. When used in the following claims, the terms“comprises,” “includes,” “have” and their conjugates mean “including butnot limited to.” The scope of the invention is limited only by thefollowing claims.

What is claimed is: 1-31. (canceled)
 32. A prosthesis comprising: aninflatable chamber defining an opening through which fluid can flow intothe inflatable chamber to fill the inflatable chamber and defining asingle cavity comprising an outer surface having one or more externalfeatures configured to facilitate engagement between the outer surfaceof the single cavity and one or both of a first tissue and a secondtissue opposite the first tissue; a rigid ring defining a lumen coupledto the opening of the inflatable chamber; and a plug configured to seatin the lumen of the rigid ring to seal the opening of the inflatablechamber, wherein the rigid ring is slidably disposed about a tubeinterfacing with the inflatable chamber in a manner to prevent fluidfrom passing through an interface between the rigid ring and the tube,wherein the prosthesis is configured to be positioned in a void space ofa joint between the first tissue and the second tissue, and wherein theinflatable chamber deforms under pressure in response to articulation ofthe joint.
 33. The prosthesis of claim 32, wherein a maximum volume ofthe inflatable chamber is in a range between 0.5 cc and 60 cc.
 34. Theprosthesis of claim 33, wherein the inflatable chamber is filled to over70% of the maximum volume of the inflatable chamber with a filler. 35.The prosthesis of claim 33, wherein the inflatable chamber is filled toless than 50% of the maximum volume of the inflatable chamber with afiller.
 36. The prosthesis of claim 33, wherein the inflatable chamberis filled to 50% to 70% of the maximum volume of the inflatable chamberwith a filler.
 37. The prosthesis of claim 33, wherein, when theinflatable chamber is filled to the maximum volume of the inflatablechamber, the prosthesis is configured to deflate upon application ofpressure to an exterior of the inflatable chamber.
 38. The prosthesis ofclaim 32, wherein the one or more external features comprise one or moreof an anchoring device, a contour of the outer surface, a shape of theouter surface as influenced by one or both of the first and secondtissues, and a friction coefficient of the outer surface.
 39. Theprosthesis of claim 32, wherein a maximum volume of the inflatablechamber is in a range between 5 cc and 100 cc.
 40. The prosthesis ofclaim 39, wherein the inflatable chamber is filled to 50% to 70% of themaximum volume of the inflatable chamber with a filler.
 41. Theprosthesis of claim 39, wherein the inflatable chamber is filled to over70% of the maximum volume of the inflatable chamber with a filler. 42.The prosthesis of claim 39, wherein the inflatable chamber is filled toless than 50% of the maximum volume of the inflatable chamber with afiller.
 43. The prosthesis of claim 39, wherein, when the inflatablechamber is filled to the maximum volume of the inflatable chamber, theprosthesis is configured to deflate upon application of pressure to anexterior of the inflatable chamber.
 44. The prosthesis of claim 32,wherein the inflatable chamber is attached to the rigid ring in a mannersuch that fluid is prevented from leaking from the inflatable chamberthrough an interface between the rigid ring and the inflatable chamber.45. The prosthesis of claim 44, wherein the inflatable chamber isattached to an exterior surface of the rigid ring.
 46. The prosthesis ofclaim 32, wherein the inflatable chamber is a fluid filled bladder. 47.The prosthesis of claim 46, wherein the fluid filled bladder is filledwith saline.
 48. The prosthesis of claim 46, wherein the fluid filledbladder is filled with a material that is different from saline.
 49. Theprosthesis of claim 48, wherein the material comprises a liquid or agel.
 50. The prosthesis of claim 46, wherein the fluid filled bladder isfilled with a biological material.
 51. The prosthesis of claim 50,wherein the biological material comprises hyaluronic acid.
 52. Theprosthesis of claim 32, wherein at least one of the inflatable chamberand the plug is formed of a biodegradable material.